CAPA - the importance of data analysis

Transcription

1 CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc sue@qmsconsultant.com QMS Consulting, Inc

2 Topics Regulatory Requirements Design Controls and CAPA Deciding what data to analyze Responsibilities and frequency Setting action limits QMS Consulting, Inc

3 FDA & ISO Requirements to Analyze Data QMS Consulting, Inc

4 Definitions Correction Action taken to eliminate a detected nonconformity Corrective Action Action taken to eliminate the cause of an actual nonconformity or other undesirable situation Preventive Action Action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation A disposition decision repair, rework, scrap Recall, Correction & Removal Corrective action is taken to manage/control recurrence Preventive action is taken to prevent occurrence QMS Consulting, Inc

5 Corrective Action vs. Preventive Action The data we analyze will distinguish Corrective Action from Preventive Action Corrective Action data source detects actual nonconformity reactive Preventive Action data analysis identifies a potential nonconformity (unfavorable trend) proactive QMS Consulting, Inc

6 ISO Requirement Corrective Action Review nonconformities (including complaints) and their causes Preventive Action Determine potential nonconformities and their causes QMS Consulting, Inc

7 FDA Requirement CAPA (a)(1) Analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products Identify existing and potential causes of nonconforming product Detect recurring problems QMS Consulting, Inc

8 21 CFR Part 820 vs. ISO Requirements Same intent ISO makes a clear distinction between Corrective Action and Preventive Action 21 CFR Part 820 is more prescriptive in terms of what should be analyzed QMS Consulting, Inc

9 (a)(1) Analyze Processes and Work Operations Consider what is relevant to your business Type of product Complexity of product Manufacturing process Complexity of the process Monitor data sources relative to the risks associated with failure Product Process Quality System QMS Consulting, Inc

10 (a)(1) (cont.) Concessions Use-As-Is disposition decisions Deviations (product, process, quality system) Temporary changes It doesn t t meet our requirements but we re using it anyway QMS Consulting, Inc

11 (a)(1) (cont.) Quality Audit Reports Internal audits and external audits Recurring audit observations Systemic observations Preamble #160: FDA wants to make it clear that corrective and preventive actions, to include the documentation of these activities, which result from internal audits and management reviews are not covered under (c) QMS Consulting, Inc

12 (a)(1) (cont.) Quality Records Evidence of compliance to your quality system Training Records Preventive Maintenance Records Environmental Monitoring Records Installation Records Servicing Records Product Returns Change Control Records QMS Consulting, Inc

13 Warning Letter Example It was revealed that your firm did not establish and maintain procedures for implementing corrective action with regard to certain user complaints of [redacted] failures. Your firm maintained that these types of failures had been investigated before, however the seventeen (17) design changes (DCN's) that were supposed to address the identified failure either did not correct the known failures or had never been implemented. QMS Consulting, Inc

14 Design Control & CAPA QMS Consulting, Inc

15 Design Control and CAPA Utilize the output of design control process to drive CAPA Intended use Essential outputs Identification of hazards and estimation of risk (analysis) Risk evaluation (mitigation) Risk control (implemented decision to control risk) QMS Consulting, Inc

16 Design Control and CAPA Design Control Considerations Product Design Manufacturability of the design Supplier Selection Serviceability Risk Management Risk Evaluation Risk Analysis Risk Control Post Production Design Planning Design Inputs Design Outputs Verification Validation Design Transfer QMS Consulting, Inc

17 Deciding What Data To Analyze Product Process Quality System QMS Consulting, Inc

18 CAPA data sources Internal External QMS Consulting, Inc

19 Internal data sources Acceptance activities (incoming, in-process, final test) Nonconforming product Process controls Environmental monitoring Equipment monitoring Change order/ecn data Design control Internal audits 3rd Party audits Supplier evaluations Management Review Device history records QMS Consulting, Inc

20 External data sources Complaints MDR s Vigilance Reporting Servicing Warranty Non-warranty Field service reports Product Returns Installation Recalls Legal Claims QMS Consulting, Inc

21 Product Data Product Process Quality System Monitor data linked to decisions implemented to control risk Controlled Environment Test Methods QC Procedures Equipment Maintenance Supplier Performance Process Monitoring Contract Manufacturer Line Clearance Warning/Cautionary Statements in Labeling Expiration Dating Service Frequency Certified Operators Operator Training Inspection QMS Consulting, Inc

22 Product Data Enable early detection Production vs. Post Production while product is still within your control QMS Consulting, Inc

23 Process Data Manufacturing Processes Characterize and evaluate processes Process validation Process controls Equipment Monitoring Automated processes Preventive Maintenance Environmental Monitoring QMS Consulting, Inc

24 Post Production Data Post Production & Complaint Management Frequency and occurrence as expected Servicing Customer Complaint Adverse Events Returned Products QMS Consulting, Inc

25 Post Production Data Questions to ask Is this a new or unknown hazard? Has the severity increased decreased? Is the rate of occurrence unexpected? Have the causes of the hazard been confirmed? Are there new causes of the hazard that have inadequate or no mitigation? Is the original risk analysis still valid? Are the risk control measures still appropriate? Update Risk Management plan as more information becomes known QMS Consulting, Inc

26 Quality System Data Quality Audits Systemic nonconformances Recurring (repeat) nonconformances QMS Consulting, Inc

27 Who analyzes the data? and when? QMS Consulting, Inc

28 Define responsibilities QSR requirements mandate that companies have staff with the training, knowledge, and experience for the job Top Managements Role Ensure adequate resources are allocated Process Owners Functional areas should routinely trend the performance of their department and act on the results QMS Consulting, Inc

29 Define the frequency Data should be examined on a regular basis Define the frequency Use a appropriate statistical methods to analyze and trend data SPC, Pareto Analysis, Control Charts, Scatter Diagrams, Histograms. QMS Consulting, Inc

30 CAPA Action Limits QMS Consulting, Inc

31 Setting Action Limits Monitor data directly linked to decisions implemented to reduce (control) risk Design FMEA Process FMEA Hazards and risk mitigation implemented Define criteria (action limits) for CAPA Not all nonconformities require Corrective Action Avoid speeding ticket syndrome QMS Consulting, Inc

32 Setting Action Limits (cont.) Determine trending points Enable early detection Where would they make the most impact? Establish limits Number of occurrences over time Define Negative Trend For example: A number of consecutive points in an unfavorable direction QMS Consulting, Inc

33 Setting Action Limits (cont.) Not all CAPAs are created equal Establish a method for prioritization based on risk Prioritize based on severity, significance and risk Significance of the issue will determine the level of investigation Convey the sense of urgency QMS Consulting, Inc

34 For Example Production and Process Controls Monitor risk control measures Design/Process FMEA Supplier, acceptance activities, line clearance, packaging, labeling, test methods, etc. Establish frequency based on risk Process monitoring (SPC data) Preventive maintenance unplanned or negative trend Environmental monitoring results with a negative trend QMS Consulting, Inc

35 For Example Complaint Process Product malfunction resulting in death or serious injury (reportable event) Design FMEA Monitor complaint data for Potential failure modes Potential failure effects Negative trend complaints per business quarter QMS Consulting, Inc

36 For Example Nonconforming Product Recurring nonconformity identified through the review of past nonconformances by Part number, lot number or, work order number Frequency of occurrence as expected? Negative trends Design/Process Product family FMEA Supplier (multiple nonconformances related to the same supplier) Defect code, cause code or reason code QMS Consulting, Inc

37 Significant issues Utilize multiple sources of data to identify significant issues Acceptance Activities Nonconforming Product Supplier Performance Installation Service Returned Product Process Monitoring Environmental Monitoring Complaints & MDR s Recalls Corrections & Removals Law Suits More QMS Consulting, Inc

38 Significant issues (cont.) Take a global approach when analyzing quality data to detect recurring problems product, process and quality system Look across business units, divisions, product families Encourage critical thinking QMS Consulting, Inc

39 Relational Data Identify relationships for multiple data sources Internal Audits & External Audits Audits & Training Records Supplier Performance & Nonconforming Product Final Inspection & Installation Design Changes & Complaints Complaints & Nonconforming Product Preventive Maintenance & Nonconforming Product QMS Consulting, Inc

40 Warning Letter Example A CAPA report was prepared as a result of several complaints related to holes observed at the hub area of ( ) Needles there is no documentation to demonstrate that potential corrective and preventive actions were discussed and evaluated QMS Consulting, Inc

41 Warning Letter Example although your firm is aware that "big flares" occur during the insert molding process of the needles causing the holes in the hub defect, you have not identified any corrective and preventive actions to prevent this problem. QMS Consulting, Inc

42 Initiate CAPA when Action limits are reached Individual high risk failure meet predefined criteria At the discretion of senior management Prioritize based on risk Consider severity and frequency of occurrence Risk to patient, user safety, business, regulatory Individual high risk failures QMS Consulting, Inc

43 Summary "The customer doesn't expect everything will go right all the time; the big test is what you do when things go wrong." -Sir Colin Marshall, CEO of British Airways QMS Consulting, Inc

44 Summary Understand the difference between corrective action and preventive action and how it relates to data analysis Utilize the output of design control to drive CAPA Define criteria for CAPA, monitor data directly linked to decisions implemented to control risk, set action limits Utilize multiple sources of data to illustrate significant issues Take a global approach to analyzing quality data to detect recurring problems QMS Consulting, Inc

45 Thank-You! Sue Jacobs QMS Consulting, Inc West Algonquin Road Hoffman Estates, Illinois USA sue@qmsconsultant.com QMS Consulting, Inc